This 3-1/2 day course for medical device manufacturers covers a wide range of topics including:

• FDA expectations regarding successful submissions and inspections, recalls, problem solving, and risk avoidance
• Scientific theory and principles of radiation sterilization
• The new global ANSI/AAMI/ISO 11137 series radiation sterilization standards
• Integration of industry standards with the FDA Quality System regulation
• Sterility Assurance Levels (SALs)
  
• Auditing processes for contract laboratories and sterilizers
  
• Radiation sterilization processing, including safety precautions, characteristics, constraints, and impact of radiation operations
  

Format
This 3-1/2-day program covers principles, processes, industry best practices, and industry standards in radiation sterilization for medical devices. This course is designed to be highly interactive between faculty and participants and will include relevant real life examples and “hands-on” exercises from a broad spectrum of medical device products.

Who Should Attend
This course is for individuals that are currently working in or with sterilization processes particularly related to radiation sterilization for medical devices. This includes design and process engineers, manufacturing and operations managers, and members of research and development or new product development teams. For participants to gain the maximum benefit from this course, it is recommended they have a working knowledge of general sterilization principles.

Faculty
In consultation with industry, government leaders, and educational experts, this course was developed to meet the medical device industry’s need for a better understanding of radiation sterilization principles, standards, and methods. The course will be taught by a mix of independent experts and industry representatives experienced in radiation sterilization. Instructors will provide a balanced presentation of radiation sterilization principles and practices as described in topics above.

Course Materials

Participants will receive the following:

• ANSI/AAMI/ISO 11137-1:2006 Sterilization of health products – Radiation – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices;
• ANSI/AAMI/ISO 11137-2:2006 Sterilization of health products – Radiation – Part 2: Establishing the sterilization dose;
• ANSI/AAMI/ISO 11137-3:2006 Sterilization of health products – Radiation – Part 3: Guidance on dosimetric aspects;
• Pertinent FDA documents; additional references; and a participant's guide for easy note-taking.

Registration Fees
Fee includes course materials, continental breakfast and refreshment breaks all four days; and lunch on the first three days of the course.

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